Preparing to make an application

The code tables provide terminology for use in product applications. Data in certain drop-down lists in a listed medicine application is populated from Code Tables. Sponsors can view this information prior to creating an application by selecting the 'Code Tables' in the TBS navigation panel.

Codes Tables that are most useful for preparing a listed medicine application are:

• Product Code
• Dosage Form Group
• Dosage Forms
• Manufacturing Steps
• Manufacturing Steps Group

Product Code

Select the product code that best describes the type of product being submitted from the drop down list. Product codes that can be used in a listed medicine application are:

Manufacturers

Listed medicines must be manufactured in accordance with Good Manufacturing Practice (GMP) (unless they are exempt from manufacturing requirements).

You must ensure that your manufacturer has a licence or clearance for the steps of manufacture required for your type of medicine and dosage form.

Manufacturing steps

There are six manufacturing steps that can be undertaken for a listed medicine application. Five of these steps are mandatory. Each step can be undertaken by more than one manufacturer but all five steps must be covered by a manufacturer.

The system will not validate and consequently not allow the medicine to be listed if the manufacturer does not hold a valid licence/certificate with the exact manufacturing step match, unless they have been licenced for a manufacturing step group which contains the specific step.

Further information about what is covered by a particular manufacturing step group or dosage form group can be found in the relevant TBS Code Table.

The following product codes are exempt from including manufacturers in the entry on the Register under Schedule 7 of the Therapeutic Goods Regulations 1990:

• Medicated space spray;
• Medicated throat lozenge;
• Medicated soap bar.

Manufacturer's licence or clearance – Product details

The product details of the manufacturer's licence/clearance will designate the dosage form, product category and manufacturing step.

For listed medicines and assessed listed medicines:

• The product category can be either Registered Therapeutic Good or Listed Therapeutic Good;

• The manufacturing step must be one of the six described in the above manufacturing step table or be a manufacturing step group that includes one of the six described steps.

  For example, the 'Finished Product Manufacturer' group includes the following individual manufacturing steps: 'Release for supply', 'Secondary packaging', 'Manufacturer of dosage form', 'Testing chemical and physical', 'Testing microbial' and 'Packaging and labelling';

• The Dosage Form must be one of the Dosage forms described in the below Dosage forms table or it can be a dosage form group which includes the dosage form that you intend to use in your listed medicine application.

Dosage forms

The dosage form is the pharmaceutical form in which a product is presented for therapeutic administration, e.g. tablet or cream. Select the dosage form that best suits the application being submitted from the drop down list.

In an application for a GMP licence or GMP clearance, single or group items can be selected. For example, the single dosage form 'Liquids' or the group dosage form 'Liquids Group'.

Dosage forms that can be used in a listed medicine application are:

All therapeutic goods containing products of animal origin must comply with the Ph. Eur general monograph 1483: Products with risk of transmitting agents of animal spongiform encephalopathies. The assessment for animal derived material must be against the principle and requirements detailed in the Ph. Eur monograph, and can be conducted:

• For low risk materials, by self-assessment; and
• For all other materials, by TGA evaluation.

Additional information can be found Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure.

You may need a pre-clearance prior to starting your application.

Subsection 9D(1) of the Act provides for variations to be made to an entry on a set of limited and prescribed circumstances. These circumstances include where information included in the register is incomplete or incorrect as a result of a mistake at the time of listing.

Before you apply, you should review the Changing a listed or assessed listed medicine: application levels and change tables to identify the relevant change type. If the change type is a 'variation' or 'correction' for a general listed medicine, you should consider submitting the change as a standard variation application (rather than a 9D(1) Variation) as this will be approved automatically by the system and the fee will be equal to or less than the fee for a 9D(1) Variation.

Where a listing has been incomplete or incorrect at time of listing, you can apply online through the TBS portal for a 9D(1) variation. Please ensure that all 9D(1) changes are made to your product within this application via the portal.

As part of this application, you will need to provide the following information:

• A copy of the original signed and dated product specifications showing the formulation of the medicine at the time of listing
• Evidence of how the mistake happened
• Advice of whether the product has already been manufactured and sold in Australia.

Once payment has been received, a delegate will review the changes made in the application, the description of changes and the supporting documentation. If your application is approved these changes will be written to the register.

Please note that your application will be assessed to ensure that your changes will not compromise the safety, quality or efficacy of your product. The delegate will also need to be satisfied that the changes do not mean that the good is separate and distinct to the manufactured medicine (as per subsection 16(1A) of the Act).